BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Magnetom Sola, Magnetom Altea and Magnetom Sola Fit

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    COPRAN ZR/ORIGIN YZ

    FDA 510(k)
    FDA Class 2 ·Dental

    SELEX/MAGNUM MODULAR HEAD 40MM -6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 22, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018